The Early Intervention and Prevention of Diabetes Foot
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 400
- Primary Endpoint
- Peripheral arterial occlusive disease
Study Overview
Brief Summary
Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure sensation, superficial pain or temperature. The most commonly used technique for diagnosis of peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC is bothersome and techniques using electric currents to measure NC and needles to study muscle innervations are uncomfortable.
Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can demonstrate neurosensory abnormalities when it is non-invasive test, selective to small fibers despite negative EMG/NCV finding.
The investigators predict QST can be used for the early diagnosis and follow-up of small-fiber neuropathy in diabetes patients. The investigators also predict the early evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to advance stage of DM foot or limb amputation.
Detailed Description
Patients will be divide into 4 groups (groups 1 to 4 will be divided by Q-Sense QST (TSA II) . The patient groups will be defined as the followings:
- Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
- Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
- Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), but no foot ulceration
- Group 4: 100 diabetes patients with neuropathy, PAOD(＋) , and foot ulceration QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Group 1: 100 diabetes patients without neuropathy, Q-Sense normal.
- •Group 2: 100 diabetes patients with neuropathy, Q-Sense abnormal but no evidence of PAOD.
- •Group 3: 100 diabetes patients with neuropathy, Q-Sense abnormal , PAOD (＋), without foot ulceration.
- •Group 4: 100 diabetes patients with neuropathy, PAOD (＋), and foot ulceration.
Exclusion Criteria
- •Poorly controlled hypertension (SBP≥150 under regular medical treatment)
- •Thyroid disease
- •Pregnancy
- •Have been diagnosed malignancy
- •Liver cirrhosis
Outcomes
Primary Outcomes
Peripheral arterial occlusive disease
Time Frame: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and severity of peripheral arterial occlusive disease ( at baseline, 6 months and 12 months).
Lipid profile
Time Frame: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and lipid profile ( at baseline, 6 months and 12 months).
Glycohemoglobin (HbA1c)
Time Frame: month 0, 6, 12
To see the correlation between diabetes neuropathy (by Q sense measurement) and glycemic control status ( at baseline, 6 months and 12 months).
Diabetes nephropathy ( macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))
Time Frame: month 0,6,12
To see the correlation between diabetes neuropathy (by Q sense measurement) and albuminuria status ( at baseline, 6 months and 12 months). Check the albuminuria status by the criteria (macro-albuminuria (UACR ≧300 mg/g) ，micro-albuminuria (UACR: 30 - 300 mg/g))
Secondary Outcomes
- Diabetes foot(month 0, 6, 12)
- major lower leg events ( lower leg amputation or revascularization)(month 0,6,12)
- Major cardiac events ( myocardial infarction, strokes and cardiac related death)(month 0,6,12)